---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-033051"
form_type: "8-K"
ticker: "TOVX"
cik: "0000894158"
company_name: "Theriva Biologics, Inc."
filed_at: "2026-03-23T23:59:59+00:00"
generated_at: "2026-05-15T09:26:25.270883+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Theriva Biologics obtains FDA agreement on Phase 3 trial design for VCN-01 in metastatic PDAC

## Summary
- FDA provided general agreement on proposed Phase 3 trial design for VCN-01 plus gemcitabine/nab-paclitaxel.
- Phase 3 trial will track successful VIRAGE Phase 2 design with repeat dosing and adaptive elements.
- FDA agreed on primary endpoint (OS), key secondary endpoints, inclusion/exclusion criteria, and dosing schedule.
- Consistent with prior EMA advice; company to finalize protocol and pursue funding or partnerships.
- VIRAGE Phase 2 met primary endpoints; improved OS, PFS, DoR for VCN-01 plus SoC vs SoC alone in metastatic PDAC.

## SEC filing metadata
- accession: 0001104659-26-033051
- form_type: 8-K
- ticker: TOVX
- cik: 0000894158
- company_name: Theriva Biologics, Inc.
- filed_at: 2026-03-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/894158/000110465926033051/0001104659-26-033051-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/894158/000110465926033051/tm269559d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-033051
- JSON: https://secwatch.observer/filing/0001104659-26-033051.json
- Plain text: https://secwatch.observer/filing/0001104659-26-033051.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.